The bipolar disorder (BD) market is highly genericized, consisting of antipsychotics, anticonvulsants, and mood stabilizers such as lithium. The atypical antipsychotic market is the most dominant of the drug classes indicated for BD, and the oral atypical antipsychotic market is highly competitive, with many generic alternatives available. Bipolar patients are typically on more than one drug for the treatment of their symptoms because of the complexity of the disease, including the cycling between manic and depressive phases. Mood stabilizers, such as lithium and valproate, tend to be the first line of therapy in the US, followed by antipsychotics such as risperidone, aripiprazole, and olanzapine, and some patients also require low-dose antidepressants. For maintenance treatment, if a patient is tolerating a certain drug, such as risperidone, then they will continue on it, but if the patient has issues with tolerability, they are normally switched to an alternative with a more benign metabolic profile or a better safety profile. 

The most recent events to have occurred in the BD space include the FDA approvals of Lundbeck’s Abilify Asimtufii (aripiprazole two-month) and Vanda’s Fanapt (iloperidone). Additionally, topline Phase IIb/III data have been released assessing NRX-101 for treatment-resistant bipolar depression with suicidal ideation and behavior, which showed a 33% reduction in suicidaility and a 76% reduction in akathisia compared to lurasidone (standard of care).